Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Phase 2

Terminated

• Conditions: Dyspepsia
• Interventions: Drug: Maytenus ilicifolia leaves infusion; Drug: Omeprazole

• Registration Number: NCT01408849
• Lead Sponsor: Casa Espirita Terra de Ismael

Brief Summary

This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-29
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Study Start: 2015-02
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• age > 18 years
• being literate
• diagnosis of dyspepsia
• initial SODA score > or = 25

Exclusion Criteria

• pregnancy
• lactation
• allergy to Maytenus species
• fail to use the drug for 3 uninterrupted weeks
• new onset serious adverse events, attributable to the drug
• patient's request

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maytenus	Maytenus ilicifolia leaves infusion	Tea of Martens ilicifolia leaves
Omeprazole	Omeprazole	Omeprazole as active comparator

Primary Outcome Measures

Name	Time	Method
SODA score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Sydney classification	8 weeks

Trial Locations

Locations (1)

Hospital das Clinicas FMRP-USP; 🇧🇷 Ribeirao Preto, SP, Brazil